National Toxicology Program (NTP); Office of Liaison, Policy and Review Meeting of the NTP Board of Scientific Counselors

AGENCY:

National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health.

ACTION:

Meeting announcement and request for comments.

SUMMARY:

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.

DATES:

The BSC meeting will be held on November 30—December 1, 2010. The deadline for submission of written comments is November 9, 2010, and for pre-registration to attend the meeting, including registering to present oral comments, is November 16, 2010. Persons needing interpreting services in order to attend should contact 301-402-8180 (voice) or 301-435-1908 (TTY). For other accommodations while on the NIEHS campus, contact 919-541-2475 or e-mail niehsoeeo@niehs.nih.gov. Requests should be made at least 7 business days in advance of the event.

ADDRESSES:

The BSC meeting will be held in the Rodbell Auditorium, Rall Building at the NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. Public comments on all agenda topics and any other correspondence should be submitted to Dr. Lori White, Designated Federal Officer for the BSC, NTP Office of Liaison, Policy and Review, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709; telephone: 919-541-9834; fax: 919-541-0295; whiteld@niehs.nih.gov. Courier address: NIEHS, 530 Davis Drive, Room K2136, Morrisville, NC 27560.

FOR FURTHER INFORMATION CONTACT:

Dr. Lori D. White (telephone: 919-541-9834 or whiteld@niehs.nih.gov).

SUPPLEMENTARY INFORMATION:

Preliminary Agenda Topics and Availability of Meeting Materials

• Report of the NIEHS/NTP Director.
• Report of the NTP Associate Director.
• Contract Concept: NTP Sperm Count and Vaginal Cytology.
• Review of the Biomolecular Screening Branch.
• Testing Program Proposed Research Projects.

The preliminary agenda, roster of BSC members, background materials, public comments, and any additional information, when available, will be posted on the BSC meeting Web site ( http://ntp.niehs.nih.gov/go/165 ) or may be requested in hardcopy from the Designated Federal Officer for the BSC (see ADDRESSES above). Updates to the preliminary agenda will also be posted to this site. The draft research concepts for the NTP testing program nominations should be available on the BSC meeting page ( http://ntp.niehs.nih.gov/go/165 ) by October 19, 2010.

Following the meeting, summary minutes will be prepared and made available on the BSC meeting Web site.

Attendance and Registration

The meeting is scheduled for November 30—December 1, 2010, beginning at 8 a.m. (Eastern Standard Time) and continuing to approximately 5:30 p.m. on November 30 and until adjournment on December 1. This meeting is open to the public with attendance limited only by the space available. Individuals who plan to attend are encouraged to register online at the BSC meeting Web site ( http://ntp.niehs.nih.gov/go/165 ) by November 16, 2010, to facilitate planning for the meeting. Registered attendees are encouraged to access the meeting Web site to stay abreast of the most current information regarding the meeting. The NTP is making plans to videocast the meeting through the Internet at http://www.niehs.nih.gov/news/video/live.

Request for Comments

Written comments submitted in response to this notice should be received by November 9, 2010. Comments will be posted on the BSC meeting Web site and persons submitting them will be identified by their name and affiliation and/or sponsoring organization, if applicable. Persons submitting written comments should include their name, affiliation (if applicable), phone, e-mail, and sponsoring organization (if any) with the document.

Time will be allotted during the meeting for the public to present oral comments to the BSC on the agenda topics. In addition to in-person oral comments at the meeting at the NIEHS, public comments can be presented by teleconference line. There will be 50 lines for this call; availability will be on a first-come, first-served basis. The available lines will be open from 7:30 a.m. until 5:30 p.m. on November 30, and 7:30 a.m. until adjournment on December 1, although public comments will be received only during the formal public comment periods, which are indicated on the preliminary agenda. Each organization is allowed one time slot per agenda topic. At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes at the discretion of the BSC chair. Persons wishing to present oral comments are encouraged to pre-register on the NTP meeting Web site and indicate whether they will present comments in-person or via the teleconference line. The access number for the teleconference line will be provided to registrants by e-mail prior to the meeting. Registration for oral comments will also be available on both meeting days, although time allowed for presentation by these registrants may be less than that for pre-registered speakers and will be determined by the number of persons who register at the meeting.

Persons registering to make oral comments are asked to send a copy of their statement or PowerPoint slides to the Designated Federal Officer for the BSC (see ADDRESSES above) by November 16, 2010, to enable review by the BSC prior to the meeting. Written statements can supplement and may expand the oral presentation. If registering on-site and reading from written text, please bring 40 copies of the statement for distribution to the BSC and NTP staff and to supplement the record.

Background Information on NTP Testing Program Nominations and Proposed Research Projects

The NTP actively seeks to identify and select for study chemicals and other substances for which sufficient information is not available to adequately evaluate potential human health hazards. The NTP accomplishes this goal through a formal, open nomination and selection process. Substances considered appropriate for study generally fall into two broad, yet overlapping categories: (1) Substances judged to have high concern as possible public health hazards based on the extent of human exposure and/or suspicion of toxicity and (2) substances for which toxicological data gaps exist and additional studies would aid in assessing potential human health risks, e.g., by facilitating cross-species extrapolation or evaluating dose-response relationships. Nominations are subject to a multi-step, formal process of review before selections for testing are made and toxicological studies are designed and implemented. The nomination review and selection process is accomplished through the participation of representatives from the NIEHS, the BSC, the NTP Executive Committee—the NTP Federal interagency policy body, and the public. The nomination review and selection process is described in further detail on the NTP Web site ( http:// ,ntp.niehs.nih.gov/,, select “Nominations to the Testing Program”).

The NTP invites interested parties to submit written comments, provide supplementary information, or present oral comments at the BSC meeting on the nominated substances and preliminary study recommendations (see “Request for Comments” below). The NTP welcomes toxicology study information from completed, ongoing, or anticipated studies, as well as information on current U.S. production levels, use or consumption patterns, human exposure, environmental occurrence, or public health concerns for any of the nominated substances. The NTP is interested in identifying appropriate animal and non-animal experimental models for mechanistic-based research, including genetically modified rodents and high-throughput in vitro test methods, and as such, solicits comments regarding the use of specific in vivo and in vitro experimental approaches to address questions relevant to the nominated substances and issues under consideration. Although the deadline for submission of written comments to be considered at the BSC meeting is November 16, 2010 (see “Request for Comments” above), the NTP welcomes comments or additional information on these study nominations at any time.

To facilitate review of the proposed research project by the BSC and the public, NTP staff developed a draft research concept document for the nomination recommended for study. A research concept is a brief document outlining the nomination or study rationale, and the significance, study approach, and expected outcome of a proposed research program tailored for each nomination. The purpose of a research concept is to outline the general elements of a program of study that would address the specific issues that prompted the nomination and the preliminary study recommendations. A research concept may also encompass larger public health issues or topics in toxicology that could be appropriately addressed through studies on the nominated substance(s). Draft research concepts should be available on the BSC meeting page ( http://ntp.niehs.nih.gov/go/165 ) by October 19, 2010.

Background Information on the NTP Board of Scientific Counselors

The BSC is a technical advisory body comprised of scientists from the public and private sectors that provides primary scientific oversight to the NTP. Specifically, the BSC advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and their overall scientific quality. Its members are selected from recognized authorities knowledgeable in fields such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral toxicology, neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. Members serve overlapping terms of up to four years. The BSC usually meets biannually.